COMMENTARY

Treating Chronic Hepatitis C Infection: A Call to Action for Primary Care Providers

Christine A. Kerr, MD; Josh S. Aron, MD

Disclosures

January 17, 2018

Chronic Hepatitis C Infection

Development of safe and effective interferon-free direct-acting antivirals (DAAs) began in 2011, sparking a dramatic transformation in the treatment of chronic hepatitis C virus (HCV) infection. Now, patients and their care providers can reasonably expect therapy to result in cure of this disease, and in place of questions about whether to treat and how to treat HCV safely, we can discuss ways to optimize and improve access to care for all patients with HCV. Toward that end, the New York State Department of Health (NYSDOH) AIDS Institute clinical guideline, "Treatment of Chronic HCV Infection With Direct-Acting Antivirals," was created with primary care providers (physicians, nurses, and physician assistants) in mind to increase the number of individuals who are treated with DAA regimens and cured of chronic HCV infection.

Highly Effective Treatment

There is no question that DAAs are effective: In real-world studies, 94% to 98% of people with all HCV genotypes were safely cured of HCV.[1] With the recent development of second-line therapies, 96% of patients, including those in whom prior treatment with DAAs has failed, can achieve a curative sustained viral response (SVR).[2] Curing HCV not only prevents liver cancer and liver failure, it also dramatically reduces all-cause mortality from 26% to 8.9%.[3] In addition, an SVR from HCV treatment improves quality of life, increases work productivity, and lowers rates of depression.[4,5]

Shifting Demographics

The abundance of safe and effective oral DAA options has revolutionized HCV care. Unfortunately, this revolution is paralleled by a disturbing demographic shift in acute HCV incidence, with a rapid rise over the past several years in the number of people aged 20-29 years who have HCV infection. This rise has been driven mostly by the opioid use epidemic.[6] In New York State, the incidence of HCV infection was once represented as a bell curve centering around baby boomers but now has a bimodal distribution, with infections in those aged 20-40 years matching infections in the older age group (Figure).[7]

Figure. Total hepatitis C by age, sex, and year. Graph on left, from 2006, was bell-shaped centering on baby boomers. Graph on right, from 2015, has a bimodal distribution, with peaks in both younger and older groups. New York State Department of Health (NYSDOH) Communicable Disease Electronic Surveillance System. Courtesy of the NYSDOH AIDS Institute.

And although there is significant hope for change through treatment, chronic HCV infection still claims more lives annually in the United States than HIV infection and remains the leading cause of liver transplantation and hepatocellular carcinoma.[8]

HCV Care Cascade

Despite a revolutionary opportunity to end the global HCV epidemic, there clearly is a need for a concerted effort to help many more people benefit from curative therapy. It is evident that we, as healthcare providers, must step up our efforts to reach and treat patients who can benefit from DAA therapy. Only 9% of the 4 million Americans living with HCV have been successfully treated.[6] HCV testing laws have been passed, yet we are still markedly undertesting, such that only 50% of those who have HCV infection know their status.[9] Changing this will further require improvements in HCV testing. Specifically, we need to shift from multistep HCV screening to reflex testing or, better yet, to point-of-care HCV testing because neither of those methods requires patients with positive antibody tests to return for follow-up diagnostic testing. HCV screening and testing strategies are further detailed in the guideline, making it easy for care providers to begin testing appropriately and effectively.

Shortage of HCV Care Providers

Ending the HCV endemic in the United States will require a great increase in the number of clinicians who can treat patients with chronic HCV. The NYSDOH AIDS Institute guideline and others like it demystify treatment protocols that were, until now, the purview of specialists.

The new DAAs are safe and remarkably easy to use... . These regimens can be used effectively in the primary care setting.

The new DAAs are safe and remarkably easy to use, and published data make clear that these regimens can be used effectively in the primary care setting.[10,11] Expanding HCV treatment to nonspecialty settings allows greater opportunity to reach and treat "difficult" populations, such as intravenous drug users, patients in federally qualified health centers, and otherwise marginalized urban and rural populations.[11,12,13]

Harm Reduction

Asking patients with hepatitis C about their drug use and sex behaviors is an essential first step toward harm reduction. Identifying practices that put patients at risk for HCV infection and offering education and interventions is necessary to avoid HCV transmission as well as prevent reinfection in those who have already achieved a virologic cure.[7] And for patients who use injection drugs, guidance towards opiate substitution programs, prevention of needle sharing, and encouraging HCV patients to bring their injection partners for evaluation will have a significant impact in removing hepatitis C from this pool.

Medical care providers who are not comfortable treating HCV should make it a priority to understand the implications of DAA therapy so that they can inform their patients about HCV treatment options and risk-reduction strategies and ensure that all who are diagnosed with HCV are linked to effective care as quickly as possible.

Changing Attitudes

Barriers still exist. Because it can be difficult to talk about risk factors for HCV, both clinicians and patients often feel uncomfortable during these conversations. Stigma still hinders linkage to care and follow-up, and HCV's dark history of difficult-to-tolerate treatments has prevented patients who know their diagnosis from seeking treatment. These barriers can be difficult to overcome but are not insurmountable. We must change attitudes among both care providers and people with HCV infection.

Design and Role of the NYSDOH Guidelines

The NYSDOH AIDS Institute clinical guideline, "Treatment of Chronic HCV Infection With Direct-Acting Antivirals," is unique in its focus on the management of patients with chronic HCV infection in primary care and other settings. The guideline emphasizes the key clinical components of pretreatment evaluation, monitoring during therapy, and posttreatment follow-up for patients with hepatitis C. It clarifies when to treat and when to refer to an experienced care provider, such as when treating patients with advanced liver and/or renal disease or when treatment may affect decisions about transplant. Ease of use is a priority with this guideline, so links to useful tools, such as calculators for staging liver disease, are included, along with links to resources for identifying drug-drug interactions and assessing and treating substance abuse and mental illness.

To address the challenge of choosing from among several available DAA options that have not been compared in head-to-head clinical trials, the guideline presents regimen options in easy-to-read charts, organized by HCV genotype and highlighting current US Food and Drug Administration-approved DAA regimens that are recommended to achieve high rates of SVR. Tables and charts simplify DAA nomenclature and provide brand and generic names. Important warnings, precautions, and drug-drug interactions are emphasized. Pregnancy and contraception are discussed. And strong recommendations are accentuated and summarized in the text.

The guideline focuses on HCV monoinfected patients but also includes a section on treatment of patients with HIV/HCV coinfection and resides within the HIV Clinical Resource website, where all NYSDOH AIDS Institute clinical guidelines are published. For clinical practitioners in the state of New York, the hepatitis C "experienced provider" is specifically defined, state testing and reporting laws are provided, and epidemiologic data demonstrating the current impact of hepatitis C within New York State are reported.

The NYSDOH HCV guideline has a universal appeal that extends beyond state lines. The HIV Clinical Resource website is a comprehensive resource for consumers and care providers. Patient support group information and HCV educational materials are provided in English and Spanish. The benefit of a guideline for primary care providers is the ability to emphasize comprehensive care, with a holistic approach to treatment of HCV and a focus on preventing reinfection. This guideline will hopefully empower practitioners to achieve this goal.

New York State Action Plan

The World Health Organization has set a goal to eliminate HCV by 2030, and New York State has already set significant benchmarks to support the goal of eradicating HCV by providing both clinical support and training through the clinical education initiative. With this new guideline, primary care providers and specialists who treat patients with chronic HCV will have an important tool for improving testing, diagnosis, linkage to care, treatment, and follow-up. We have the tools we need to end HCV; now we need to act.

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